Kornimate/medical-research-clean huggingface dataset:
grace - graduated response for advanced copd with enhanced support

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Summary: the aim of this study is to explore the feasibility and potential for a positive impact of a graduated response for advanced copd with enhanced support. the study is a randomized controlled trial of: * systematic needs assessment * advance care planning * crossectoral virtual conferences. researchers will compare quality of life and healthcare use of the intervention group with a control group that will be assessed for intervention need at the last follow-up.

the current study is a non-blinded randomized controlled pilot trial. the control group will be offered treatment as usual whereas the intervention group will be allocated to the grace model of care. in total, 100 patients and their caregivers will be included. the patients are all community dwelling and attached to the outpatient respiratory medicine clinic at hvidovre hospital. the patients will be randomized by block randomization to intervention and control group with a ratio of 1:1. furthermore, the patients will be stratified according to which municipality they belong to, to ensure we gather feasibility data from two municipalities. the control group will be offered to be assessed for their eligibility for palliative care through the existing visitation conference at the end of the trial period. endpoints include: patient-reported (quality of life, anxiety and depression, self-efficacy), caregiver-reported ( caregiver burden, anxiety and depression, well-being) and patient healthcare use.

Eligibility criteria:
inclusion criteria: * copd * exacerbation within the last year * living in høje taastrup or copenhagen * cognitively relevant * clinical frailty scale 6+ * icecap-scm at least two scores of: 1. 1, 2 2. 1, 2 3. 1, 2 4. 1, 2 5. 1, 2, 3 6. 1, 2 7. 1, 2 exclusion criteria: * dementia * psychosis * substance abuse * hearing or speech impairment * cancer * receiving specialized palliative care or other similar interventions * immediately dying

Keywords: copd palliative care cross-sectoral
mobile methods for reducing obesity risk in parents and children

Conditions: Overweight and Obesity; Overweight; Obesity

Summary: the purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity.

this is a 6-month randomized controlled trial comparing the efficacy of two smartphone-based dietary and weight change interventions among 70 parent-child dyads with at least one child between the ages of 2 and 12 (70 adults and 70 children ages 2-12). one intervention group (simple) will use a simplified, low-burden form of dietary tracking in the study smartphone application and the other group (standard) will use standard calorie tracking. components of both interventions include (1) setting personalized goals for weight, dietary intake, and daily activity (2) adaptive text message interventions based on behavior change techniques such as goal setting and in-the-moment progress feedback several times per week, (3) weekly tailored feedback updated in the study smartphone app, and (4) weekly lessons on the smartphone app. the primary objective is to promote weight loss in the parents, and the secondary objective is to determine if one or both interventions produce a ripple effect of parent dietary change onto dietary changes in the child.

Eligibility criteria:
inclusion criteria (parent): * currently age 21-55. * body mass index (bmi) of 25-50 kg/m². * have one child between the ages of 2-12. * own an iphone running at least ios11 with a data and text messaging plan. * have the ability to read, write, and speak english. inclusion criteria (child): * currently age 2-12. exclusion criteria (parent): * lost more than 10 pounds in the last 6 months. * currently participating in another nutrition or weight loss program. * currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity. * currently pregnant or breastfeeding, pregnant within the past 6 months, or planning to become pregnant within the next 6 months. * planning to relocate in the next 8 months. * will be out of town for 2 weeks or more in the next 8 months. * cannot attend two visits at the unc weight research program clinic. * pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the par-q (physical activity readiness questionnaire). * treatment of diabetes with insulin or oral medications that may cause hypoglycemia. * history of clinically diagnosed eating disorder. * diagnosis of schizophrenia or bipolar disorder. * hospitalization for a psychiatric diagnosis within the last year. * report a past diagnosis of or current symptoms of alcohol or substance dependence. * another member of the household (family member or roommate) is a participant or staff member in this study.
a study of abt-414 in participants with newly diagnosed glioblastoma (gbm) with epidermal growth factor receptor (egfr) amplification

Conditions: Glioblastoma; Gliosarcoma

Summary: this study seeks to determine whether the addition of abt-414 to concomitant radiotherapy and temozolomide (tmz) followed by combination of abt-414 with adjuvant tmz prolongs overall survival (os) among participants with newly diagnosed glioblastoma (gbm) with epidermal growth factor receptor (egfr) amplification. in addition, there is a phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of abt-414 in participants with newly diagnosed egfr-amplified gbm who have mild or moderate hepatic impairment.


Eligibility criteria:
inclusion criteria: * must have a clinical diagnosis of glioblastoma (gbm). * must have a confirmed epidermal growth factor receptor amplification in tumor tissue. * must have a karnofsky performance status (kps) \>= 70 at assessment \<= 14 days prior to randomization (n/a to the sub-study). * must have recovered from effects of surgery, postoperative infection and other complications of surgery. * must have adequate bone marrow, renal, and hepatic function (for the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment). exclusion criteria: * multifocal, recurrent or metastatic gbm or gliomatosis cerebri (for the sub-study, the participant can have multifocal gbm and glimatosis cerebri but can't have recurrent or metastatic gbm). * prior chemo therapy or radiosensitizer for head and neck cancer. * prior radiotherapy to the head or neck in overlap of radiation fields. * prior therapy for glioblastoma or other invasive malignancy. * prior, concomitant or planned treatment with novo tumor treatment fields (novo-ttf), egfr-targeted therapy, bevacizumab, gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Keywords: newly diagnosed glioblastoma epithelial growth factor receptor (egfr) temozolomide abt-414 radiology therapy oncology group antibody drug conjugate brain tumor brain tumor group egfrviii egfr amplified first line therapy brain cancer
safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (t2dm) on background therapy with pioglitazone

Conditions: Diabetes Mellitus, Type II

Summary: this study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (t2dm) who are receiving background treatment with pioglitazone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus, diagnosed at least 3 months prior to screening (visit 1) * bmi 20 to 48 kg/m2, inclusive * hba1c 7.0% - 10.0%, inclusive * age 18 to 85 years, inclusive exclusion criteria: * currently taking more than one oral hypoglycemic agent * type 1 diabetes mellitus
cidp07 rozanolixizumab post trial access program (the pta)

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Summary: this post trial access (pta) program enables access to rozanolixizumab for eligible patients who have taken part in the cidp04 trial (nct04051944) and are continuing to derive benefit from treatment.


Eligibility criteria:
inclusion criteria: * patient who has taken part in the cidp04 (nct04051944) study * patient who derives continued benefit from treatment * all required safety information has been reported as per local laws/regulations, reported to bionical, as appropriate, and documented in the patient's medical records * patient is not pregnant exclusion criteria:

Keywords: chronic inflammatory demyelinating polyradiculoneuropathy cidp ucb7665 rozanolixizumab
prospective prostate cancer and patient-reported outcomes registry

Conditions: Prostate Cancer; Adenocarcinoma of the Prostate; Locally Advanced Prostate Carcinoma; Locally Advanced Prostate Adenocarcinoma

Summary: this study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * pathology confirmed diagnosis of localized or locally advanced prostate cancer * being able to speak, read and understand dutch, french, or english * each patient (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he understands the purpose of, and is willing to participate in the study. exclusion criteria: * patients with prior treatment for prostate malignancies will be excluded. * dementia, mental alteration, or psychiatric pathology that can compromise informed consent from the patient and/ or adherence to the protocol and the monitoring of the trial * patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical. * persons deprived of liberty or under guardianship
neck muscle activation in patients with long standing problems after a whiplash trauma registered with ultrasound with speckle tracking

Conditions: Whiplash Associated Disorder

Summary: today there is evidence for that neck specific exercises reduce neck pain problems in patients with mechanical neck pain. however, there is a lack of consensus on how to optimize neck exercises and dosages in neck rehabilitation. more knowledge is needed to determine which and how muscles are activated in exercises thought to be neck-specific. there is neither enough knowledge of differences in neck muscle activation between patients with long standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle function improved with specific neck exercises. one approach would be a real time study of deformation and deformation rate in different layers of neck muscles in patients with residual long-term neck pain and disability after a whiplash trauma. the purpose of the present study was to investigate deformation and deformation rate in different layers of dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder elevation. forty patients with long standing (more than 6 months but less than 3 years)patients and 40 controls matched for age and gender will be included for comparisons between patients and healthy in neck muscle activation. the investigators also include 60 patients with whiplash trauma, of those 30 patients will be randomized to a. neck specific exercises in a 3 months period and b. will 30 be on a waiting list for 3 months. measurements are performed at baseline and at 3 months follow-up. those patients who fulfilled the 3 months period of neck specific exercises will also be asked for a 6 months follow-up.


Eligibility criteria:
inclusion criteria: * wad ii and iii * age 18-63 years * remaining problems * right handed * pain on right or on both sides. exclusion criteria: * myelopathy * earlier fracture or luxation of the cervical column, earlier neck injury * spinal tumour * spinal infection * surgery in the cervical column * malignity * systemic disease or other disease or another injury contraindicated to perform the treatment program or the measurements * diagnosed severe psychiatric disorder * unconscious in connection to the trauma * known drug abuse * lack of familiarity with the swedish language

Keywords: neck spine muscles activity coordination
relationship between body composition, food consumption, and micro and macronutrients with gene expression in breast cancer

Conditions: Breast Cancer; Endocrine Therapy; Endocrine Therapy Adverse Reaction; Vitamin D Deficiency; Nutrition Disorders; Obesity

Summary: the protocol involves measurement of 25 hidroxy vitamin d, gene expression of cytochrome and vitamin d receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.


Eligibility criteria:
inclusion criteria: * breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy * signed consent exclusion criteria: * mental retardation

Keywords: vitamin d adverse cytochrome p450 vdr nutrients gene expression tamoxifen anastrozole exemestane
aqcs for detection of early cancer and precancerous lesions on upper gastrointestinal tract

Conditions: Esophagogastroduodenoscopy

Summary: the purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of egd.

investigators developed a real-time quality control system of esophagogastroduodenoscopy(egd) named egd automatic quality-control system (aqcs). investigators carried a prospective multicenter randomized controlled trial to assess the performance of this system in quality control of real-time egd, including detecting the early upper gastrointestinal cancer and precancerous lesions, assessing inspection completeness, mucosal visibility, time of egd procedure and other indicators.

Eligibility criteria:
inclusion criteria: * patients aged 40-80 years old * patients scheduled for white light egd examination with anaesthesia * american society of anesthesiology risk class 1, 2 or 3 exclusion criteria: * patients with known advanced esophageal or gastric cancer * patients with a history of esophageal or gastric surgery * patients scheduled for therapeutic egd * patients with stenosis or obstruction of upper gastrointestinal tract * patients with a history of serious anesthesia-related complications * patients in pregnancy or lactation phase * patients refused to sign the informed consent

Keywords: esophagogastroduodenoscopy gastric cancer esophageal cancer artificial intelligence quality-control
nicotine and sensorimotor replacement for smoking in smokers with schizophrenia

Conditions: Tobacco Use Disorder; Schizophrenia

Summary: the objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.

this study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content \[vlnc\] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine \[nic\] vs. placebo \[pla\] patches) in smokers with schizophrenia and control smokers without psychiatric illness. each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: vlnc + nic, vlnc + pla, no cigarettes + nic, no cigarettes + pla, usual brand cigarettes + no patches. next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.

Eligibility criteria:
inclusion criteria: * schizophrenia or no psychiatric illness * 18 and older * men and women * cigarette smokers, 20-50 cigarettes per day * would like to quit someday exclusion criteria: * medical conditions excluding transdermal nicotine replacement * pregnancy or lactation

Keywords: nicotine craving dual-diagnosis comorbidity
pegzilarginase in subjects <24 months old with arginase 1 deficiency

Conditions: Arginase 1 Deficiency

Summary: this is an open-label, multicentre study to evaluate the safety, pk, and activity (pd) of weekly subcutaneous (sc) administration of pegzilarginase in subjects with arg1-d who are \< 24 months of age. the study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.

caeb1102-301a is an open-label, single-arm, non-controlled, repeat dosing, multicentre study to evaluate the safety, pk, and activity (pd) of weekly sc administration of pegzilarginase over 12 weeks in subjects with arg1-d who are \< 24 months of age. this study will consist of: * a screening period of up to 4 weeks to ensure the subjects meet the study eligibility criteria and establish baseline plasma arginine * a treatment period of 12 weeks * a safety follow-up period of 8 weeks with visits 1 week and 8 weeks after the last dose.

Eligibility criteria:
inclusion criteria: 1. subjects must be \< 24 months of age on the date of informed consent 2. confirmed diagnosis of arg1-d documented in medical records by at least 1 of the following methods: 1. elevated plasma arginine levels 2. a mutation analysis revealing a pathogenic variant 3. red blood cell (rbc) arginase activity 3. subjects must weigh \> 8 kg due to clinical trial related blood collection volumes required 4. written informed consent by parent/legal guardian, in accordance with national stipulations, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol 5. at least one value of plasma arginine ≥ 180 μm during screening 6. documented confirmation from the investigator and/or dietitian that the subject can: 1. attempt to maintain a stable, age-appropriate level of protein consumption, including natural protein, and eaa supplementation within approximately ± 15% of dietitian recommended diet 2. attempt to maintain current use of ammonia scavengers, if prescribed exclusion criteria: 1. other medical condition(s) or comorbidity(ies) that, in the opinion of the investigator, would interfere with study compliance or data interpretation 2. hyperammonaemic episode (plasma ammonia levels \> 100 μm) with ≥ 1 symptom related to hyperammonaemia requiring hospitalisation or emergency room management within the 4 weeks before the first dose of study drug 3. active infection requiring anti-infective therapy within \< 2 weeks before first dose of study drug 4. known active infection with human immunodeficiency virus, hepatitis b, or hepatitis c 5. history of hypersensitivity to polyethylene glycol (peg) or any of the excipients included in the study drug that, in the judgment of the investigator, puts the subject at unacceptable risk for aes 6. currently participating in another therapeutic clinical study or has received any investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to first dose of study drug 7. previous liver or haematopoietic stem cell transplant 8. use of botulinum toxin within 16 weeks prior to first dose
drug-drug interaction between idx719, simeprevir, tmc647055 and ritonavir when administered in combination in healthy participants (mk-1894-007)

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the potential for a pk drug-drug interaction when idx719, simeprevir, tmc647055 and low-dose ritonavir (rtv) are administered in combination. safety and tolerability will also be assessed.


Eligibility criteria:
inclusion criteria: * agrees to use a double method of birth control (one of which must be a barrier) from screening through at least 90 days after the last dose of the study drug * male participants agree not to donate sperm from day -1 through 90 days after the last dose of study drug exclusion criteria: * is pregnant or breastfeeding * has another clinically significant medical conditions or laboratory abnormality(s)

Keywords: chronic hepatitis c hepatitis c virus hcv
efficiency of the quadratus lumborum block for post-operative analgesia in abdominoplasty surgery

Conditions: Quadratus Lumborum Block; Abdominoplasty; Analgesia; Locoregional Anesthesia

Summary: abdominoplasty is a common surgical procedure in plastic surgery which causes postoperative pain and may delay patients' recovery. surgery is potentially associated with a number of postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or digestive ... although they do not inevitably lead to a life-threatening prognosis, in many cases these complications delay post-operative recovery. defined in the 1990s by professor henry kehlet's danish team, rapid rehabilitation after planned surgery is an approach to overall patient care that aims to rapidly restore previous physical and mental capacities and thus significantly reduce mortality and morbidity. pain management is at the heart of this program and local anesthesia techniques are at the heart of early rehabilitation programs. described for just over a decade, quadratus lumborum block (qlb) have shown their effectiveness for analgesia in abdominal, or orthopedic, or obstetrical surgery. considering the anatomical territory concerned, this locoregional anesthesia technique seems to be very interesting in abdominoplasty to allow early rehabilitation of the patient.


Eligibility criteria:
inclusion criteria: * adult patients admitted for programmed dermo-lipectomy surgery with or without associated liposuction. exclusion criteria: * pregnant woman * patient under 18 years of age * subject under guardianship or curators * patient allergic to local anesthetics * infection at the puncture sites * patient on morphine analgesic over the long term * patient on antidepressants for neuropathic pain.

Keywords: quadratus lumborum block abdominoplasty analgesia locoregional anesthesia